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Medfusion recallZ-0078-2024 · Smiths Medical ASD Inc. · initiated Aug 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

FDA root cause category: Under Investigation by firm

What the company is doing

Smiths Medical sent an URGENT MEDICAL DEVICE CORRECTION notice to its direct consignees on 08/16/2023 by traceable mailing. The notice explained the issue, potential risk to the patient, and requested the following actions be taken: Customer Required Actions 1. Locate all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Ensure all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession have undergone all tests in the Annual Maintenance List including the new Force Sensor Check within the past 12 months, including new pumps that have not yet undergone annual maintenance. 3. Complete and return the attached Response Form to [email protected] within ten days of receipt to acknowledge your understanding of this notification. 4. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]

Recall details

Recall number
Z-0078-2024
Status
Open, Classified
Initiated by the company
Aug 16, 2023
Posted by the FDA
Oct 6, 2023
Recalling firm
Smiths Medical ASD Inc.
Quantity
20383 pumps
Product code
FRN
FDA submissions
K040899
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6

Code information (models, lots, serial numbers)

a) 0600-00, UDI/DI 10610586041259; b) 0600-01, UDI/DI 10610586041242; c) 0600-50, UDI/DI 10610586043284; d) 0600-51, UDI/DI 10610586043291; e) 0600-82, UDI/DI 10610586043017; f) 0600-249, UDI/DI 10610586041297; All serial numbers

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K040899 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92956).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page